Multiple Reaction Monitoring (MRM) Versus I 125 Radioimmunoassay (RIA) for the Quantification of Orexin-A/Hypocretin-1 Levels in Cerebrospinal Fluid: a Prospective Diagnostic Validation Study in Patients With Hypersomnolence

Status: Recruiting
Location: See location...
Intervention Type: Diagnostic test
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

In humans, selective loss of orexin neurons is responsible for type 1 narcolepsy (NT1), or narcolepsy with cataplexy, or orexin deficiency syndrome. The International Classification of Sleep Disorders 3rd edition (ICSD-3) distinguishes between hypersomnolence of central origin: NT1, narcolepsy type 2 (NT2), or narcolepsy without cataplexy, and idiopathic hypersomnia (HI). These rare conditions are all characterised by hypersomnolence (excessive daytime sleepiness, or excessive need for sleep), which is the primary and often most disabling symptom. A level of ORX-A in cerebrospinal fluid (CSF) (\<110 pg/mL) is a very sensitive and specific biomarker of NT1, currently sufficient for the diagnosis of this condition. In contrast, ORX neurons are thought to be intact in IH and NT2, and the pathophysiological mechanisms underlying these diseases remain unknown. Thus, their diagnosis is based solely on clinical and electrophysiological criteria. The objective of this project is to determine the validity of a mass spectrometric technique for the determination of ORX-A in the cerebral spinal fluid of patients suffering from hypersomnolence in comparison with the radioimmunoassay which is the reference technique.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 8
Healthy Volunteers: f
View:

• Age ≥ 8 years

• Complaint of hypersomnolence and suspected central hypersomnolence

• Benefiting from a standardised assessment: clinical, biological and neurophysiological

• Lumbar puncture necessary for the assessment

• Sufficient cerebrospinal fluid taken for biological analysis (at least 1 ml)

• Signed informed consent

Locations
Other Locations
France
University Hospital of Montpellier
RECRUITING
Montpellier
Time Frame
Start Date: 2023-02-15
Estimated Completion Date: 2025-10-30
Participants
Target number of participants: 117
Sponsors
Leads: University Hospital, Montpellier

This content was sourced from clinicaltrials.gov